Influenza is an important cause of acute respiratory infections (ARI) worldwide. Seasonal influenza causes an estimated 250,000-500,000 deaths and 3-5 million severe illnesses each year (WHO, 2009), and pandemic 2009 H1N1 influenza has caused morbidity and mortality worldwide. In Kenya, influenza accounts for up to 50% of all ARI during the peak influenza season, based on Kenyan Ministry of Public Health and Sanitation and KEMRI/CDC surveillance data. Influenza vaccine has been shown to reduce influenza-associated ARIs in developed countries. However, little is know about the effectiveness of influenza vaccine in the developing world. In Kenya, a commercial trivalent injectable vaccine is licensed, but less than 30,000 doses are sold annually. The International Emerging Infections Program (IEIP) under KEMRI/CDC currently conducts population-based disease surveillance (PBDS) for severe acute respiratory illness (SARI) and influenza-like illness (ILI) in two sites in Kenya, Lwak (Nyanza province) and Kibera (Nairobi). The investigators propose to conduct a three-year influenza vaccine effectiveness study using the commercially available southern hemisphere seasonal vaccine for 2010, which includes the pandemic 2009 H1N1 component, and for 2011 and 2012. The study will evaluate the effectiveness of the vaccine in preventing laboratory-confirmed influenza, non-specific ARIs at the clinic and household level, and secondary influenza infection and secondary ARIs. Our study hypothesis is: Immunizing children with influenza vaccine will decrease influenza-associated acute respiratory infections among children and may reduce the number of non-specific acute respiratory infections in vaccinated children and their household contacts.

Look at the number of Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members in both households that have a vaccinated child versus households that didn't have a vaccinated child

Biospecimen Retention: Samples With DNA

Nasopharyngeal and oropharyngeal swabs.Potentially has DNA and RNA retained.

Children between 6months- 10years of age who have received the influenza vaccine

Biological: Seasonal influenza vaccine

annual recommended Southern Hemisphere vaccine

Other Name: Vaxigrip

Unvaccinated group

Eligible children between 6months and 10years who didn't receive the influenza vaccine

Biological: Seasonal influenza vaccine

annual recommended Southern Hemisphere vaccine

Other Name: Vaxigrip

Detailed Description:

Vaccine will be donated by Sanofi Pasteur in a quantity large enough to vaccinate the eligible population. Vaccine will be made available to infants from 6 months of age through children up to 10 years old. This includes an age group that is at high risk for severe outcomes (<5 years) and an age group (school-age children, 5-10) that is considered most likely to spread the infection.

Ascertainment of Influenza Illness:

Primary Outcome Measure

• Laboratory-confirmed influenza infection

Secondary outcome measures

Medically attended ILI, SARI

Community-reported ILI SARI

Laboratory-confirmed influenza, medically attended ILI and SARI, and community-reported ILI and SARI in non-immunized household members

In Lwak and Kibera, field workers visit households weekly and encourage residents to go to the free clinic if they have respiratory symptoms. Currently, from KEMRI/CDC surveillance data, in Kibera, approximately 57 % of people in the catchment area seek medical care for ILI (Range: 62% children - 52% adults) and of those people who seek care, 72% seek care at Tabitha clinic. In Lwak, approximately 77% of people in the catchment area seek medical care for ILI (Range: 75% children - 80% adults) and of those people who seek care, 34% seek care at Lwak clinic.

The surveillance for ILI and SARI will continue as usual, with weekly field worker (also called community interviewer) household visits, clinic-based surveillance for ILI and SARI at Tabitha clinic and Lwak clinic, and sampling of all patients who meet the case definition for ILI and SARI

Eligibility

Ages Eligible for Study:

6 Months to 10 Years (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Vaccine will be made available to children six months of age to 10 years in the Kibera and Lwak catchment areas enrolled in the International Emerging Infectious Disease Program( IEIP) conducted by KEMRI/CDC.

Criteria

Inclusion Criteria:

Age 6months -10 years

Enrolled in the IEIP morbidity study

Exclusion Criteria:

Age less than 6 months or greater than or equal to 11 years

Not enrolled in the IEIP morbidity study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432340

Locations

Kenya

KEMRI/CDC- IEIP surveillance-Asembo

Kisumu, Western, Kenya

KEMRI/CDC IEIP surveillance- Kibera

Nairobi, Kenya

Sponsors and Collaborators

Centers for Disease Control and Prevention

Kenya Ministry of Health

Kenya Medical Research Institute

Sanofi Pasteur MSD

Investigators

Principal Investigator:

Mark A Katz, MD

Center for Disease Control and Prevention-Kenya

Principal Investigator:

Robert Breiman, MD

Centers for Disease Control and Prevention

Principal Investigator:

Joshua Mott, PhD

Centers for Disease Control and Prevention

More Information

Publications:

World Health Organization. Acute Respiratory Infections (Update September 2009). 2009. Available at http://www.who.int/vaccine_research/diseases/ari/en/print.html